MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ROLLATOR, EMPOWER, BLACK, MB

Catalog Number MDS86845BK

Device Problem Mechanical Problem (1384)

Patient Problem Hip Fracture (2349)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

According to the customer, when standing up from the seat he "leaned back" and the rollator "folded and collapsed" causing him to fall to the floor, "fracture his pelvis", and hit his head.The customer reported he was taken to the emergency room where they confirmed the fracture with an "xray" and performed a "cat scan" on his head.The customer reported the "cat scan" was negative for injuries.The customer reported the physician stated he did not require surgery for the fracture and it would take "12 weeks to heal".The customer reported the emergency room prescribed him "tylenol" and "tramadol" for the pain.The customer reported it was recommended he make an appointment with an "orthopedic" physician and a "chiropractor".The customer reported the "va" replaced his rollator.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, when standing up from the seat he "leaned back" and the rollator "folded and collapsed" causing him to fall to the floor, "fracture his pelvis", and hit his head.

Manufacturer Narrative

Update d9- returned to manufacturer.Update h3- device evaluated by manufacturer.Update h6(b)- type of investigation.Update h6(d)- investigation conclusions.

• Type of Device: ROLLATOR, EMPOWER, BLACK, MB
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 18739334
• MDR Text Key: 335758277
• Report Number: 1417592-2024-00080
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86845BK
• Device Lot Number: 86723020004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other